Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name urinary homocystine (nonquantitative) test system
510(k) Number K112790
Device Name AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
LUNA PLACE
DUNDEE,,  GB DD2 1XA
Applicant Contact KAREN HILL
Correspondent
AXIS-SHIELD DIAGNOSTICS, LTD.
THE TECHNOLOGY PARK
LUNA PLACE
DUNDEE,,  GB DD2 1XA
Correspondent Contact KAREN HILL
Regulation Number862.1377
Classification Product Code
LPS  
Date Received09/26/2011
Decision Date 05/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-